This section highlights FDA-related milestones and regulatory updates for drugs developed by Inhibrx Biosciences (INBX).
Over the past two years, Inhibrx Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INBRX-106 and INBRX-109. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
INBRX-106 FDA Regulatory Events
INBRX-106 is a drug developed by Inhibrx Biosciences for the following indication: refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INBRX-106
- Announced Date:
- May 11, 2026
- Indication:
- refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda.
Announcement
Inhibrx Biosciences, Inc. announced positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study.
AI Summary
Inhibrx Biosciences announced positive interim results from the randomized, first-line Phase 2 portion of the HexAgon study evaluating INBRX-106 plus pembrolizumab. The company said the combination showed encouraging activity that supports continued development.
The safety profile was generally manageable and consistent with adding an immunostimulatory agent to checkpoint blockade. The most common treatment-related adverse events were rash, diarrhea, fatigue, and infusion-related reactions, and these were predominantly low-grade. No treatment-related deaths were reported in either arm.
Progression-free survival data from this Phase 2 portion are expected in the fourth quarter of 2026. Inhibrx plans to begin the randomized Phase 3 portion of HexAgon in the third quarter of 2026.
INBRX-106 is a hexavalent OX40 (CD134) agonist built on Inhibrx’s single-domain antibody platform to drive strong T-cell activation; more than 175 patients have been treated with the molecule so far.
Read Announcement- Drug:
- INBRX-106
- Announced Date:
- December 16, 2025
- Indication:
- refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda.
Announcement
Inhibrx Biosciences, Inc. announced an update on the INBRX-106 Phase 2/3 clinical trial in combination with Keytruda® (pembrolizumab) as a first-line treatment for patients with locally advanced unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and the Phase 1/2 trial evaluating patients with checkpoint inhibitor refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda.
AI Summary
Inhibrx is advancing INBRX-106 in combination with Keytruda as a first-line option for patients with unresectable or metastatic head and neck squamous cell carcinoma (HNSCC) and in checkpoint inhibitor–refractory or relapsed non‑small cell lung cancer (NSCLC). The randomized Phase 2 portion for HNSCC has enrolled 46 of 60 planned patients (PD‑L1 CPS ≥20) and randomizes 1:1 to INBRX-106 plus Keytruda versus Keytruda alone; the primary endpoint is overall response rate, with duration of response, progression‑free survival and safety as key secondary measures. Enrollment is expected to finish in Q1 2026.
The Phase 1/2 NSCLC cohort completed enrollment of 34 patients in November 2025; primary endpoints include objective response rate, disease control rate, duration of response and safety. Current datasets for both trials are not yet mature; Inhibrx expects data in the second half of 2026 to indicate whether INBRX-106 plus Keytruda shows superior and sustained benefit over current standard care. INBRX-106 is an engineered OX40 agonist being tested only in combination with Keytruda in these studies.
Read Announcement
INBRX-109 FDA Regulatory Timeline and Events
INBRX-109 is a drug developed by Inhibrx Biosciences for the following indication: Conventional Chondrosarcoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- INBRX-109
- Announced Date:
- April 21, 2026
- Indication:
- Conventional Chondrosarcoma
Announcement
Inhibrx Biosciences, Inc. announced updated interim data from its Phase 1/2 study evaluating ozekibart (INBRX-109) in combination with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer (CRC).
AI Summary
Inhibrx reported updated interim data from its Phase 1/2 study of ozekibart (INBRX-109) given with FOLFIRI in patients with locally advanced or metastatic, unresectable colorectal cancer. With an April 10, 2026 cutoff, the colorectal cancer cohort showed a compelling signal of activity despite heavy prior treatment.
Of 45 evaluable patients, about 70% received ozekibart as a fourth-line therapy, and roughly 80% had progressed on prior irinotecan-based regimens. These figures highlight that responses were seen in a population that had already failed multiple standard therapies, suggesting the combination may have meaningful clinical activity in a difficult-to-treat group.
Ozekibart is a precision-engineered, tetravalent antibody that activates death receptor 5 (DR5) to favor tumor cell death. Inhibrx will present the updated results in a live webcast on April 21, 2026 at 1:30 p.m. Pacific Time to discuss the findings further.Read Announcement
- Drug:
- INBRX-109
- Announced Date:
- October 23, 2025
- Indication:
- Conventional Chondrosarcoma
Announcement
Inhibrx Biosciences, Inc. announced positive topline results from the registrational ChonDRAgon study (n= 206) investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma.
AI Summary
Inhibrx Biosciences reported that the registrational ChonDRAgon study of ozekibart in advanced or metastatic, unresectable chondrosarcoma met its primary endpoint of median progression-free survival. Ozekibart reduced the risk of progression or death by 52%, with a hazard ratio of 0.48 (95% CI: 0.33, 0.68) and more than doubled median PFS to 5.52 months versus 2.66 months for placebo.
Benefit was consistent across IDH-wild and IDH-mutant patients. Key secondary endpoints reinforced this result, with a disease control rate of 54% versus 27.5%, and delayed worsening in pain and physical function. Ozekibart was generally well tolerated, with the most common treatment-related side effects being fatigue, constipation, and nausea. Early liver risks were mitigated by patient screening and close monitoring.
Inhibrx plans to file a biologics license application in Q2 2026 and will present full data at an upcoming conference.
Read Announcement- Drug:
- INBRX-109
- Announced Date:
- October 22, 2025
- Indication:
- Conventional Chondrosarcoma
Announcement
Inhibrx Biosciences, Inc. announced that it will host a live webcast presentation on Thursday, October 23, 2025 at 1:30 p.m. Pacific Time to provide topline results from the registrational ChonDRAgon study investigating ozekibart (INBRX-109) as a single agent versus placebo in patients with advanced or metastatic, unresectable chondrosarcoma.
AI Summary
Inhibrx Biosciences, a clinical-stage biopharmaceutical company, will host a live webcast presentation on Thursday, October 23, 2025 at 1:30 p.m. Pacific Time. During this event, the company plans to share topline results from its registrational ChonDRAgon study of ozekibart (INBRX-109).
The ChonDRAgon trial is a randomized, blinded, placebo-controlled study testing ozekibart as a single agent in patients with advanced or metastatic, unresectable chondrosarcoma. Topline data will show how ozekibart performs compared to placebo in this rare bone cancer. The company will also update on expansion studies of ozekibart combined with FOLFIRI in late-line colorectal cancer and with irinotecan plus temozolomide in refractory Ewing sarcoma.
Investors may join the webcast at https://app.webinar.net/RdZmlEPaEyw or listen by calling 1-888-880-3330 (conference ID 9577647). A replay will be available for 60 days in the Investors section of the Inhibrx website.
Read Announcement- Drug:
- INBRX-109
- Announced Date:
- January 21, 2025
- Indication:
- Conventional Chondrosarcoma
Announcement
Inhibrx Biosciences, Inc. announced preliminary efficacy and safety data from the Phase 1 trial of ozekibart (INBRX-109) in combination with FOLFIRI for the treatment of advanced or metastatic, unresectable colorectal adenocarcinoma (CRC).
AI Summary
Inhibrx Biosciences announced encouraging preliminary data from its Phase 1 trial evaluating ozekibart (INBRX-109) with FOLFIRI in patients with advanced or metastatic, unresectable colorectal adenocarcinoma. In the trial, 10 of 13 patients were evaluated using RECIST v1.1 criteria. Among these patients, there was one complete response, three partial responses, and six cases of stable disease. Durable disease control lasting 180 days or more was observed in nearly half of the patients, with a median progression-free survival of 7.85 months. Notably, responses were seen even in patients who had undergone multiple prior lines of therapy, including those who had previously failed FOLFIRI. The reported treatment-related adverse events were generally mild to moderate. Based on these promising results, Inhibrx is now expanding the trial to a larger, more uniform patient group to further assess ozekibart’s efficacy and safety.
Read Announcement
